Tag : Annualized Bleeding Rate

The United States (US) Food and Drug Administration (FDA) has approved marstacimab-hncq, an anti-tissue factor pathway inhibitor, for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A (HA) without factor VIII inhibitors or hemophilia B (HB) without factor IX inhibitors (neutralizing antibodies). The approval was based on results from the phase 3 BASIS trial, which showed a reduction in the annualized bleeding rate (ABR) with marstacimab-hncq compared to on-demand treatment and routine prophylaxis in patients with HA or HB without inhibitors.